PharmacokineticsPhase 1NCT00645554
A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers
A Phase 1 study testing Galantamine oral solution in people with Pharmacokinetics, run by Xian-Janssen Pharmaceutical Ltd..
Trial summary
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet. Read more about this study
- Who is it for?
- Ages 18 to 48 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Galantamine oral solution
- Type of treatment
- Pill or oral medicine
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients must meet the following criteria: body weight index is between 18-28 kg/m2
- Patients are deemed healthy based on physical examination, medical history, vital signs, electrocardiogram and results of clinical laboratory tests
- All patients must be able to read and understand the contents of informed consent that must be signed prior to any trial-specific procedures are done.
Who cannot join
- Patients meeting one or more of the following criteria cannot be included in the study: the patient uses disallowed medicine, which is any prescribed medication within the last 2 weeks or OTC drugs within the last week prior to dosing (or at least 5 half lives for any drug ingested). Patients who have taken any non-prescribed systemic or topical medication may still be entered into the study, if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety
- The subject has history of alcohol or drug abuse
- Patient has been treated with an investigational drug within 30 days prior to screening
- Patient has a know hypersensitivity to galantamine or has a history of severe drug allergy or hypersensitivity
- Patient has any serious illness such as liver or renal insufficiency, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, metabolic and other chronic disturbance
- Patient has donated blood within 60 days prior to dosing
- Patient is a moderate or severe smoker who smokes more than 3 cigarettes, or ex-smokers who has ceased smoking for at least 3 months prior to dosing
- Patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any other reason
About this study
Official title: A Bioequivalent Study to Compare Galantamine Oral Solution With Marketed Galantamine Capsule After Single Oral Administration of 10 mg.
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.
Read the detailed description
This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet. All patients are healthy male patients who are 18-45 years old with BWI (Body Weight Index) between 18-28 kg/m2. All patients must sign informed consent before being enrolled. 24 patients were randomized in the study. The duration of study is 9 days. All patients must stay at site unit for 12 hours after single oral administration otherwise patients could stay home but must return to site at specific date and time. The day before dosing day (baseline), patients were randomized to one of the two groups to be administered either 4mg galantamine oral solution (1ml) or galantamine tablet (1 tablet). After 7-day washout period, patients were crossed over to receive the other formulation. Pharmacokinetic observation will last to 32 hours after dosing. Plasma were collected at immediately before dosing and 0.25, 0.5, 0.75, 1.5, 2, 3, 4, 6, 8, 12, 24 and 32 hours after dosing to determine plasma concentration of galantamine. Safety and tolerance evaluation will last until Day 9. Safety evaluation include adverse events, vital signs, physical examination, electrocardiogram and laboratory tests. On study Day 1, patients will take either 4mg galantamine oral solution (1ml) or 4mg galantamine tablet (1 tablet). After 7-day washout period, on Day 8, patients will cross over to take the other formulation, the dosage and administration are the same.
- Conditions
- Pharmacokinetics
- Being tested
- Galantamine oral solution
- Keywords
- Galantamine oral solution, Galantamine tablet, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine oral solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
It is estimated that the plasma maximal concentration of galantamine (Cmax=31.53mg×L-1) after single oral administration can be reached in Chinese young volunteers at the peak time of 1.66 hours. The half life is 7.06 hours.
Secondary outcomes (1)
The relative bioavialibility of galantamine oral solution (4mg) indicated by AUC0-t and AUC0-inf are 105.6%±18.5% and 106.2%±19.5% respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xian-Janssen Pharmaceutical Ltd. Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645554
- Sponsor's protocol ID
- CR002848
- Status last verified
- Mar 2010
- First submitted
- 24 Mar 2008
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalent Study to Compare Galantamine Oral Solution With Marketed Galantamine Capsule After Single Oral Administration of 10 mg.
- ClinicalTrials.gov ID
- NCT00645554
- Acronym / sponsor ID
- CR002848
- Conditions
- Pharmacokinetics
- Keywords
- Galantamine oral solution, Galantamine tablet, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study completion
- Sep 2004 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.
Detailed description
This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet. All patients are healthy male patients who are 18-45 years old with BWI (Body Weight Index) between 18-28 kg/m2. All patients must sign informed consent before being enrolled. 24 patients were randomized in the study. The duration of study is 9 days. All patients must stay at site unit for 12 hours after single oral administration otherwise patients could stay home but must return to site at specific date and time. The day before dosing day (baseline), patients were randomized to one of the two groups to be administered either 4mg galantamine oral solution (1ml) or galantamine tablet (1 tablet). After 7-day washout period, patients were crossed over to receive the other formulation. Pharmacokinetic observation will last to 32 hours after dosing. Plasma were collected at immediately before dosing and 0.25, 0.5, 0.75, 1.5, 2, 3, 4, 6, 8, 12, 24 and 32 hours after dosing to determine plasma concentration of galantamine. Safety and tolerance evaluation will last until Day 9. Safety evaluation include adverse events, vital signs, physical examination, electrocardiogram and laboratory tests. On study Day 1, patients will take either 4mg galantamine oral solution (1ml) or 4mg galantamine tablet (1 tablet). After 7-day washout period, on Day 8, patients will cross over to take the other formulation, the dosage and administration are the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients must meet the following criteria: body weight index is between 18-28 kg/m2
- Patients are deemed healthy based on physical examination, medical history, vital signs, electrocardiogram and results of clinical laboratory tests
- All patients must be able to read and understand the contents of informed consent that must be signed prior to any trial-specific procedures are done.
Key exclusion criteria (8 listed)
- Patients meeting one or more of the following criteria cannot be included in the study: the patient uses disallowed medicine, which is any prescribed medication within the last 2 weeks or OTC drugs within the last week prior to dosing (or at least 5 half lives for any drug ingested). Patients who have taken any non-prescribed systemic or topical medication may still be entered into the study, if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety
- The subject has history of alcohol or drug abuse
- Patient has been treated with an investigational drug within 30 days prior to screening
- Patient has a know hypersensitivity to galantamine or has a history of severe drug allergy or hypersensitivity
- Patient has any serious illness such as liver or renal insufficiency, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, metabolic and other chronic disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galantamine oral solution | Drug | – |
Primary outcome
It is estimated that the plasma maximal concentration of galantamine (Cmax=31.53mg×L-1) after single oral administration can be reached in Chinese young volunteers at the peak time of 1.66 hours. The half life is 7.06 hours.
1 secondary outcome
The relative bioavialibility of galantamine oral solution (4mg) indicated by AUC0-t and AUC0-inf are 105.6%±18.5% and 106.2%±19.5% respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- A bioequivalent study of galantamine oral solution comparing with galantamine tablet in healthy Chinese male subjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Janssen Pharmaceutical Ltd. Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galantamine oral solution in people with Pharmacokinetics, run by Xian-Janssen Pharmaceutical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It is estimated that the plasma maximal concentration of galantamine (Cmax=31.53mg×L-1) after single oral administration can be reached in Chinese young volunteers at the peak time of 1.66 hours. The half life is 7.06 hours.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.